FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECG App
K Number: K201525
·
Decision Oct 8, 2020
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
8
Applicant Total
12
Review Days
122
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Basic Information
- Device Name
- ECG App
- K Number
- K201525
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2345
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apple, Inc.
- Date Received
- June 8, 2020
- Decision Date
- October 8, 2020
- Product Code
- QDA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QDA | Electrocardiograph Software For Over-The-Counter Use | FDA class 2 | Cardiovascular |
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Fitbit ECG App
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Other Clearances by Apple, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253582 | Medical Imaging Calibration Feature (MICF) | Apr 1, 2026 | Substantially Equivalent |
| K250507 | Hypertension Notification Feature (HTNF) | Sep 11, 2025 | Substantially Equivalent |
| K250143 | Digital Prism Correction Feature (DPCF) | Jun 23, 2025 | Substantially Equivalent |
| K242058 | Digital Prism Correction Feature (DPCF) | Oct 21, 2024 | Substantially Equivalent |
| K240929 | Sleep Apnea Notification Feature (SANF) | Sep 13, 2024 | Substantially Equivalent |
| DEN230081 | Hearing Aid Feature (HAF) | Sep 12, 2024 | Unknown |
| K231173 | Irregular Rhythm Notification Feature (IRNF) | Jul 21, 2023 | Substantially Equivalent |
| K213971 | Atrial Fibrillation History Feature | Jun 3, 2022 | Substantially Equivalent |
| K212516 | IRNF App | Oct 22, 2021 | Substantially Equivalent |
| DEN180044 | ECG App | Sep 11, 2018 | Unknown |